The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial.

ABSTRACT:

Introduction

Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.

Methods and analysis

A pragmatic, multicentre, non-inferiority randomised controlled trial.

Primary outcome measure

The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression

SUBMITTER: Abdel-Fattah M 

PROVIDER: S-EPMC5724064 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature